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BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients

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ClinicalTrials.gov Identifier: NCT00099502
Recruitment Status : Completed
First Posted : December 16, 2004
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Bayer

December 15, 2004
December 16, 2004
December 19, 2008
November 2003
Not Provided
Hazard ratio for relapses [ Time Frame: During the first and during the second 52 weeks ]
Prime objective: For IFNB-1b, comparison of a 500µg (16 MIU) dose to the currently approved dose (250 µg; 8 MIU), s.c. e.o.d., with regard to safety, tolerability and efficacy in patients with relapsing remitting MS (RRMS).
Complete list of historical versions of study NCT00099502 on ClinicalTrials.gov Archive Site
  • Time to confirmed Expanded Disability Status Score (EDSS) progression [ Time Frame: After 52 and after 104 weeks ]
  • Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images [ Time Frame: After 104 weeks ]
Co-prime objective: Comparison of the safety, tolerability and efficacy of IFNB-1b e.o.d. and Copaxone 20 mg given s.c. o.d.; Time to confirmed EDSS progression; MRI: Change from screening in volume of black holes after 104 weeks.
Not Provided
Not Provided
 
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

The purpose of this study is to determine

  • whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms
  • whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
    250mcg administered s.c. every other day
  • Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
    500mcg administered s.c. every other day
  • Drug: Copaxone
    20 mg administered s.c. once daily.
  • Experimental: Arm 1
    Intervention: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
  • Experimental: Arm 2
    Intervention: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
  • Active Comparator: Arm 3
    Intervention: Drug: Copaxone
O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F, Filippov V, Groth M, Knappertz V, Kraus C, Sandbrink R, Pohl C, Bogumil T; BEYOND Study Group, O'Connor P, Filippi M, Arnason B, Cook S, Goodin D, Hartung HP, Kappos L, Jeffery D, Comi G. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Oct;8(10):889-97. doi: 10.1016/S1474-4422(09)70226-1. Epub 2009 Sep 2. Erratum in: Lancet Neurol. 2011 Feb;10(2):115. Lancet Neurol. 2009 Nov;8(11):981. Lancet Neurol. 2012 Jan;11(1):27. Cree, B [added]; Harung, H-P [corrected to Hartung, H-P].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2244
2100
August 2007
Not Provided

Inclusion Criteria:

  • Female and male patients
  • Aged 18-55 years
  • Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0
  • Treatment-naive to IFNB or Copaxone

Exclusion Criteria:

  • Neurological progression at disease onset or between relapses
  • Serious or acute heart diseases
  • History of severe depression or suicide attempt
  • Serious or acute liver, renal or bone marrow dysfunction
  • Monoclonal gammopathy
  • Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
  • Pregnancy or lactation
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Latvia,   Netherlands,   Norway,   Poland,   Russian Federation,   Slovenia,   Spain,   Sweden,   Switzerland,   Ukraine,   United States
 
 
NCT00099502
91162
EudraCT: 2005-002235-27
306440
Beyond
Yes
Not Provided
Not Provided
Therapeutic Area Head, Bayer HealthCare Pharmaceuticals, Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP